TELFAST 120 mg FILM-COATED TABLETS

2. What you need to know before taking Telfast

Do not take Telfast

• If you are allergic to fexofenadine or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Telfast if:

• you have liver or kidney problems.
• you have or have had cardiovascular disease, as this medicine may cause a fast or irregular heartbeat.

• you are an elderly patient.

If you are in any of these situations or are unsure, consult your doctor before taking Telfast.

Other medicines and Telfast

Tell your doctor or pharmacist if you are taking or have recently taken or may take any other medicine.

If you are taking apalutamide (a medicine for prostate cancer), as the effect of fexofenadine may decrease.

Indigestion remedies containing aluminum and magnesium may affect the action of Telfast, reducing the amount of medicine absorbed.

It is recommended to leave an interval of about 2 hours between taking Telfast and the indigestion remedy.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Telfast if you are pregnant, unless necessary.

Telfast is not recommended during breastfeeding.

Driving and using machines

It is very unlikely that Telfast will affect your ability to drive or operate machinery. However, you should make sure that when taking these tablets you do not feel drowsy or dizzy before driving or operating machinery.

Telfast contains sodium.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Telfast

Follow the administration instructions of this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults and children from 12 years of age

The recommended dose is 1 tablet (120 mg) once a day.

Take the tablet with water before meals.

The effect of the medicine starts after 1 hour and lasts 24 hours.

If you take more Telfast than you should

If you take many tablets, consult your doctor or pharmacist, or go to the emergency department of the nearest hospital. The symptoms of overdose in adults are dizziness, drowsiness, fatigue, and dry mouth.

In case of overdose or accidental ingestion, consult the Toxicology Information Service (telephone 91 562 04 20).

If you forget to take Telfast

Do not take a double dose to make up for forgotten doses.

Take the next dose at the usual time indicated by your doctor.

If you stop taking Telfast

Consult your doctor if you want to stop taking Telfast before finishing the treatment. If you stop taking Telfast before planned, you may experience symptoms again.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Consult your doctor immediately and stop taking Telfast if you notice that:

• your face, lips, tongue, or throat swell and you have difficulty breathing, as these may be symptoms of a severe allergic reaction.

The following unwanted effects have been reported in clinical trials, with an incidence similar to that observed in patients who did not receive the medicine (placebo).

Common side effects(may affect up to 1 in 10 people):

• headache
• drowsiness
• feeling unwell (nausea)
• dizziness.

Uncommon side effects(may affect up to 1 in 100 people):

• fatigue / tendency to sleep

Other side effects(frequency not known: cannot be estimated from available data) that may occur are:

• difficulty sleeping (insomnia)
• sleep disorders
• nightmares
• nervousness
• fast or irregular heartbeat
• diarrhea
• skin rash and itching
• hives
• severe allergic reactions that may cause swelling of the face, lips, tongue, or throat, shortness of breath, chest tightness, and difficulty breathing.
• blurred vision.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Telfast

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Telfast 120 mg

The active ingredient is fexofenadine hydrochloride. Each film-coated tablet contains 120 mg of fexofenadine hydrochloride.

The other ingredients are:

Core components: microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, magnesium stearate.

Coating components: hypromellose, povidone, titanium dioxide (E171), colloidal anhydrous silica, macrogol, and red iron oxide (E 172) and yellow iron oxide (E172).

Appearance of the product and package contents

Telfast 120 mg are film-coated tablets, 6.1 x 15.8 mm in size, oblong in shape, and pale orange in color, engraved with "012" on one side and an "e" written on the other side.

Telfast is available in blisters. Each tablet is inside the blister.

Telfast is available in packs of 2 (only samples), 7, 10, 15, 20, 30, 50, 100, and 200 (10x20) tablets per pack.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/ Roselló i Porcel, 21

08016 - Barcelona

Spain

Sanofi Group

Manufacturer

Sanofi-Winthrop Industrie

Avenue Gustave Eiffel, 30 – 36

Tours (France)

or

Opella Healthcare International SAS

56, route de Choisy

60200 Compiègne (France)

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Allegra 120 mg Filmtabletten

Belgium: Allegratab 120 mg filmomhulde tabletten

Croatia: Allegra 120 mg filmom obložene tablete

Denmark: Telfast, filmovertrukne tabletter 120 mg

Finland: Telfast 120 mg tabletti, kalvopäällysteinen

Germany: Telfast 120 mg-Filmtabletten

Greece: Allegra

Ireland: Telfast 120 mg film-coated tablets

Italy: Telfast 120 mg compresse rivestite con film

Luxembourg: Allegratab 120 mg comprimés pelliculés

Malta: Telfast 120 mg film-coated Tablets

Portugal: Telfast 120, comprimidos revestidos por película

Slovenia: Telfast 120 mg filmsko obložene tablete

Spain: Telfast 120 mg comprimidos recubiertos con película

Sweden: Allegra

United Kingdom: Telfast 120 mg film-coated tablets

Date of the last revision of this leaflet:September 2023

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/61910/P_61910.html

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/